Surgical implants and related methods and systems

ABSTRACT

Described are surgical implants, tools, systems, and related methods, useful for implantation of surgical implants, such as those used to treat pelvic conditions including but not limited to incontinence; an implant may features such as a stiffened non-flat form; a suture running; a system may include a surgical implant as described and an installation tool; methods may include a method of preparing a surgical implant and a method of implanting a urethral sling.

PRIORITY CLAIM

The present non-provisional patent Application claims benefit from U.S.Provisional Patent Applications having U.S. Ser. No. 60/650,208, filedon Feb. 4, 2005, by Arnal et al., and titled TRANSOBTURATOR SLING FORMEN; U.S. Ser. No. 60/650,209, filed on Feb. 4, 2005, by Arnal et al.,titled TRANSOBTURATOR SLING FOR MEN; U.S. Ser. No. 60/659,714, filed onMar. 8, 2005, by Arnal et al., titled NEEDLE DESIGN FOR MALETRANSOBTURATOR SLING; U.S. Ser. No. 60/659,504, filed on Mar. 8, 2005,by Arnal, titled NEEDLE DESIGN IMPROVEMENTS FOR MALE TRANSOBTURATORSLING; U.S. Ser. No. 60/677,457, filed on May 4, 2005, by Hauschild etal., titled URETHRAL SLING OF KNITTED MESH WITH EDGE TREATMENT; and U.S.Ser. No. 60/683,185, by Arnal, filed May 20, 2005, titled TRANSOBTURATORSURGICAL SLING DELIVERY SYSTEM AND METHOD, and U.S. Ser. No. 60/650,207,filed on Feb. 4, 2005, by Rehder et al., titled TRANSOBTURATOR SLING FORMEN, wherein the entirety of said provisional patent applications areincorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to surgical articles, implants, and componentssuitable for a implantation of devices in the pelvic regions.

BACKGROUND

Surgical implants for use in the pelvic region are fast becomingimportant for an aging population. Pelvic tissue conditions are becomingmore common, such as incontinence and tissue prolapse, in females andmales. One example of a pelvic implant to treat such a condition is theurethral sling, is useful for treating incontinence. Other examplesinclude similar implants are useful for treating, e.g., pelvic organprolapse such as vaginal prolapse.

New methods are being developed for improving safety and efficacy ofthese implants and methods of installation. Recent developments have ledto methods of implantation that use a transobturator tissue path. See,for example, Assignee's copending U.S. patent application Ser. No.11/064,875, filed Feb. 24, 2005, by Anderson et al., and titledTransobturator Surgical Articles and Methods. The use of a tissue paththat traverses the obturator foramen calls for new features of surgicalimplants and systems that allow ease of installation and good efficacyand functioning of an implant during chronic implantation.

With these new surgical approaches, there is continuing need to improveurethral sling implants to be as effective, safe, and easy to install aspossible, with long-lasting efficacy of treatment.

SUMMARY

The invention relates to implants that can be used with transobturatoror other implantation techniques, to treat a pelvic condition such asprolapse, incontinence, etc. Implants and systems are designed for easeof use (e.g., installation), short-term fixation, long-term fixation,and overall strength and efficacy.

Short-term fixation refers to the ability of an implant to maintainpositioning during and shortly after installation, before tissueingrowth into pores of the sling. Good short-term fixation can allow asignificant (upwards to about 7 lbs.) force to be applied to an implant(e.g., urethral sling), after installation, without causing the implantto move out of position or allow a reduction of the amount of force(e.g., compression) placed on the implant by the physician at surgery.

Long-term fixation refers to the ability of an implant to maintainpositioning after tissue ingrowth, chronically, e.g., for the life ofthe patient. Good long-term fixation can allow an installed implant toexperience and withstand pressure pulses and other forces from thepatient, while maintaining the position of the implant and the tissuethat the implant was meant to approximate or support, without breakingor experiencing stress elongation or relocation over time.

Useful features of an implant that provide ease of use include ease ofinstallation (e.g., movement through tissue), good conformity of theimplant to tissue, the ability of a surgeon to readjust an implantduring an installation procedure, e.g., after a sheath has been removedfrom an end portion of a sling.

In one aspect, the invention relates to a surgical implant that includesa central support portion and an elongate end portion attached to thecentral support portion. The end portion includes multiple layers ofmaterial.

In another aspect the invention relates to a surgical implant thatincludes a central support portion and an elongate end portion attachedto the central support portion. The implant includes a stiffenednon-flat form.

In another aspect the invention relates to a method of implanting apelvic implant. The method includes providing an implant; providing abiological adhesive; installing the implant to contact pelvic tissue ofa patient; and applying biological adhesive to tissue, implant, or both,to secure the implant.

In another aspect the invention relates to a surgical implant thatincludes an elongate end portion. The end portion includes a suturerunning along a length of the end portion and the suture is attached atmultiple attachment points.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A, 1B, and 1C illustrate exemplary implants of the invention.

FIG. 2 illustrates an exemplary implant of the invention.

FIG. 3 illustrates an exemplary implant of the invention.

FIG. 4 illustrates an exemplary implant of the invention.

FIG. 5 illustrates an exemplary implant of the invention.

FIGS. 6A, 6B, and 6C illustrate exemplary implants of the invention.

FIGS. 7A, 7B, 7C, 7D, 7E, and 7F, illustrate exemplary implants of theinvention.

FIG. 8 illustrates an exemplary implant of the invention.

FIG. 9 illustrates an exemplary implant of the invention.

FIG. 10 illustrates an exemplary implant of the invention.

FIG. 11 illustrates an exemplary implant of the invention.

FIGS. 12A and 12B illustrate an exemplary tool for use in a kit orsystem of the invention.

FIG. 13 illustrates an exemplary tool for use in a kit or system of theinvention.

DESCRIPTION

Surgical methods of the invention include methods of implanting a pelvicimplant such as a urethral sling (“sling”). The implant can be used totreat a condition such as tissue or organ prolapse, urinaryincontinence, or another condition involving pelvic tissue. Exemplarymethods involve a “transobturator” tissue path whereby an implanttraverses the obturator foramen. Embodiments of the invention relate tosurgical techniques, implants, tools, and related systems, kits, andassemblies, generally useful for implantation methods, e.g., involvingthis transobturator technique.

“Transobturator” methods generally involve two lateral incisions at theleft and right inner thigh regions, each near a patient's obturatorforamen, and a third, medial external incision at the perineum orvagina. The implant is installed between the medial incision and the twolateral incisions with a central support portion of the sling beingplaced to support pelvic tissue such as the urethra. For treatingincontinence, the implant supports the urethra, optionally by notnecessarily by directly contacting the urethra. By some methods acentral support portion can contact tissue below the urethra thatsupports the urethra, such as the corpus spongiosum. The implant may betensioned to approximate pelvic tissue, e.g., to improve continence. SeeAssignee's copending U.S. patent application Ser. No. 11/347,047,entitled “TRANSOBTURATOR METHODS FOR INSTALLING SLING TO TREATINCONTINENCE, AND RELATED DEVICES,” filed Feb. 3, 2006, and incorporatedherein by reference.

Inventive features described herein can be used with pelvic implants foruse in supporting pelvic tissue such as urethral slings configured andparticularly suitable for treating stress urinary incontinence (SUI)diagnosed with urethral hypermobility or intrinsic sphincter deficiencyin both men and women. A urethral sling or other pelvic implant asdescribed herein can be implanted to treat SUI or other urologicaldisorders such as urge incontinence, mixed incontinence, overflowincontinence, functional incontinence, prolapse (e.g. vaginal),enteroceles (e.g. of the uterus), rectoceles, cystocele, and anatomichypermobility.

Exemplary implants useful with respect to the invention can be urethralsling implants. These may be of any shape or form, and can be elongatedand rectangular for treating SUI. For other treatments, e.g., to providehammock support for the bladder or bladder neck, or to address arectocele, enterocele or prolapse, the implant may be any of a widevariety of other shapes and configurations. As an example, a urethralsling may be of the general shape of the slings described and shown inMoir et al., “The Gauze-Hammock Operation”, Journal of Obstetrics andGynaecology of the British Commonwealth, Volume 75, No. 1, pps. 1-9(1968). Thus, as used herein, the terms “urethral sling” and “implant”are used generally to encompass a wide variety of shapes and sizes,materials, and treatments.

Exemplary implants (e.g., urethral slings) can include a central supportportion and “extension” portions (or “end portions”), the centralsupport portion being useful to support a specific type of pelvic tissuesuch as the urethra, bladder, corpus spongiosum, or vaginal tissue. Thecentral support portion can be sized and shaped to contact the desiredtissue when installed, e.g., as a sling, and support the pelvic tissue.

End portions connected to and extending from a central support portioncan be useful to attach to other anatomical features to provide furthersupport for the central support portion and the supported pelvic tissue.Multiple (e.g., two or four) end portions can extend from the centralsupport portion as elongate “ends,” “arms,” or “extensions,” that areused to attach to other anatomy, such as by extending through a tissuepath to an external incision or to an internal anchoring point. See,e.g., US patent publication number 2005/0080317, having U.S. Ser. No.10/684,861, filed Oct. 14, 2003, the entirety of which is incorporatedherein by reference.

As a specific example of a urethral sling, a urethral sling may includea widened central support portion to provide increased area of contactbetween the central support portion of the sling and the tissue beingsupported, preferably and optionally in combination with a load transferportion between end portions and the central support portion. SeeAssignee's U.S. patent application Ser. No. 11/346,750, entitled “TRANSOBTURATOR SURGICAL ARTICLES AND METHODS,” filed Feb. 3, 2006, andincorporated herein by reference.

Exemplary pelvic implants can include support portions that can includeor consist of a central support portion, two elongate end portionsextending oppositely from the central support portion, and aload-transfer portion between an end portion and the central supportportion. The implant and the support portions of the implant have alengthwise direction that is considered to be in the direction of theelongate length of the end portions, and a width that is transverse tothe lengthwise direction.

End portions connected to and extending from a load-transfer portion canbe useful to attach to other anatomical features to provide support forthe central support portion and the supported pelvic tissue. Two endportions can extend from the central support portion as elongate “ends,”“arms,” or “extensions,” that are used to attach to other anatomy, suchas by extending through a tissue path to an external incision or to aninternal anchoring point, and optionally through the obturator foramen.

Dimensions of an implant can be as desired and useful for any particularinstallation procedure, treatment, and to support a particular tissue.Dimensions of an exemplary urethral implant for transobturatorimplantation can be sufficient to allow an end portion to extend from alateral incision located adjacent to an obturator foramen of a patient,through the obturator foramen, and then to or near a medial incision(e.g., a vaginal incision in a female or a perineal incision in a male).An opposite end portion has sufficient length to extend from the medialincision, through the opposite obturator foramen, and to another lateralincision adjacent to the opposite obturator foramen. Length and widthtolerances account for a range of human anatomy sizes and for aninstallation procedure.

The central support portion is of sufficient length to at leastpartially surround a pelvic tissue to support the tissue to treatincontinence, such as to support the urethra or corpus spongiosum(optionally in combination with some or a portion of the length of theload-transfer portions). A width of a central support portion is greaterthan a width of end portions and is sufficiently wide to increasecontact area and frictional forces between a central support portion anda tissue in contact with the central support portion. Exemplary lengthsof a central support portion of a urethral sling can be in the rangefrom 0.5 to 2 centimeters, such as from 0.7 to 1.8 centimeters.Exemplary widths of a central support portion of a urethral sling can bein the range from 1.5 to 4 centimeters, such as from 2 to 4 centimeters.

According to urethral sling embodiments, the combined length of two endportions, a central support portion, and one or more load-transferportions, can be approximately 16 inches (about 41 centimeters), e.g.,within the range from 35 cm to 50 cm. Alternate lengths can also beused.

A width of a urethral sling implant can be as desired and as useful,consistent with the description herein, optionally including a centralsupport portion that is wider than a width of an end portion. A width ofan end portion can be a width useful for implanting the implant and forproviding desired strength and fixation properties during and followingimplantation and optional tensioning of the sling. Typical widths of endportions of a urethral sling can be in the range from 0.5 to 1.5centimeters, e.g., from 0.8 to 1.2 centimeters. End portions cantypically have a uniform or substantially uniform width along thelength, normally not varying by more than about 25 percent of theaverage width along the length of the installed portion of the endportion.

Exemplary urethral sling implants for use in transobturator methods,e.g., for treating incontinence in males, can include a central supportportion that exhibits a width that is greater than a width of the endportions, e.g., the width of the end portion at a location that isadjacent to the load-transfer portion. See Assignee's U.S. patentapplication Ser. No. 11/346,750, entitled “TRANSOBTURATOR SURGICALARTICLES AND METHODS,” filed Feb. 3, 2006, and incorporated herein byreference. A central support portion that has a width that is greaterthan a width of the end portions can improve contact between the implantand tissue to be supported by the implant, e.g., the urethra, corpusspongiosum, etc. An increased width of a central support portion maytake the form of one or two lateral extensions that extends (i.e.,increases) the width of the central support portion in at least onedirection (an anterior direction) for contacting tissue that isrelatively anterior to a patient's anatomy compared to an otherwisesimilar central support portion that exhibits a smaller width.Alternately, a central support portion may include two lateralextensions in each of an anterior lateral direction and a posteriorlateral direction, to contact tissue that is both anterior and posteriorto a central support portion of a relatively more narrow width.

An increased width, e.g., in an anterior direction, can provide forincreased contact and frictional engagement between a central supportportion and pelvic tissue such as a urethra, bladder neck, vaginaltissue, corpus spongiosum, etc., being supported. A widened centralsupport portion provides a larger area of contact between the implantand a pelvic tissue and can have a reduced tendency to fold or deformupon tensioning of the implant. Increased contact area between a centralsupport portion and pelvic tissue can further allow for improved abilityto re-locate or approximate tissue if desired during implantation of animplant and treatment and support of pelvic tissue.

Adjacent to a central support portion, and connecting the centralsupport portion to one or preferably to both end portions, can be one ortwo load-transfer portions. See, e.g., FIGS. 7D, 7E, and 7F, whichillustrate and specify load transfer portions of exemplary urethralsling implants. Additional examples of slings that include a centralsupport portion and load-transfer portions are illustrated at Assignee'sU.S. patent application Ser. No. 11/346,750, entitled “TRANSOBTURATORSURGICAL ARTICLES AND METHODS,” filed Feb. 3, 2006, and incorporatedherein by reference. The load-transfer portion exhibits a width that isgreater than a width of an end portion, such as the width of the endportion at the location at which the end portion connects to theload-transfer portion. The load-transfer portion also includes a widththat is less than the width of a widened central support portion.Functionally, the load-transfer portion allows a load placed across thecentral support portion, between the end portions, to be distributedacross a width of the central support portion that is greater thanwidths of the end portions.

The dimensions of load-transfer portions can be sufficient to allow forthe functional capabilities of a load-transfer portion as describedherein, and to allow for overall functional capabilities of an implant.Exemplary dimensions of a load-transfer portion for use as a urethralsling, may include a length extending between an end portion and acentral support portion of from about 0.2 to about 2 centimeters, suchas from about 0.3 to about 1.0 centimeters. The width of a load transferportion normally varies between the width of the central support portion(where the load-transfer portion connects to the central supportportion), and the width of the end portion (where the load-transferportion connects to the end portion). The width can increase graduallyalong the length between the end portion and the central supportportion, either in a straight line, a curved or arcuate line, orotherwise, as desired.

A urethral sling may preferably include two load-transfer portions, oneconnecting each end portion to the central support portion. Aload-transfer portion may extend laterally (i.e., uni-laterally) in ananterior direction toward a central support portion that is widened inan anterior direction. Alternately a load-transfer portion may extendbi-laterally in an anterior direction and in a posterior direction,toward a central support portion that is widened bi-laterally in bothanterior and posterior directions.

A load-transfer portion may extend between an end portion and a centralsupport portion by a path along an edge that results in a width of aload transfer portion that gradually changes from the width of the endportion to the width of the central support portion. This changing widthmay define a path, along the edge of the load-transfer portion, that isstraight, arcuate, or a combination of straight and arcuate, and thatfunctionally allows a load placed across the central support portion,between the end portions, to be distributed across a width of thecentral support portion that is greater than widths of the end portions.An advantage of a load-transfer portion as described is that the widthof the load-transfer portion, being greater than the width of an endportion, allows for a force applied across the central support portionto be spread out across a greater width of the central support portion(compared to an implant that does not include a load-transfer portion asdescribed herein). Spreading the force to a width that is at leastgreater than the width of the end portions can reduce or preventdeformation of the central support portion upon placing a force acrossthe central support portion. Deformation can be in the form of “curling”of the central support portion when a load is placed in oppositedirections along the end portions.

Materials useful for an implant (e.g., support portion, extensionportion, central support portion, etc.) can be any of a variety ofsynthetic or biologic materials now known or developed in the future.Exemplary end and support portions can be prepared from any combinationof synthetic and biologic or natural materials. For example, an endportion or a support portion may be made of a synthetic mesh. An implantof a central support portion and two end portions may be made entirelyof a one-piece continuous mesh cut to the size and shape of the centralsupport portion and two end portions. In other embodiments, exemplaryend portions can be of synthetic material and a central support portioncan be of a different type of a synthetic material or of a biologicmaterial. Components of a multi-piece or multi-material implant may bepre-attached or pre-assembled, e.g., attached during manufacture, so asurgeon is not required to spend significant time cutting, connecting,or otherwise assembling the pieces of an implant prior to a surgicalinstallation procedure.

A synthetic implant material may be in any form, such as a continuous,solid, or semi-continuous (e.g., perforated) film; or in the form ofcombined fibers or strands, e.g., a braided, knit, tied, mesh, woven,non-woven, or fabric-type of material; or combinations of these. Certainembodiments of implants include a synthetic implant portion in the formof a polymeric mesh material. The mesh material includes one or morewoven, knit, or inter-linked polymeric filaments or fibers that formmultiple fiber intersections or “junctions” throughout the mesh. Thefiber junctions may be formed via weaving, knitting, braiding, knotting,joining, ultrasonic welding, use of an adhesive, or otherjunction-forming techniques, including combinations thereof, leavingopenings or pores (“interstices”) between elements of the connectedfibers. The size of the pores may be sufficient to allow tissuein-growth and fixation within surrounding tissue upon implantation.

A synthetic implant material can be any synthetic material that can beuseful in an implantable surgical device such as a biocompatiblepolymeric material or a biocompatible non-polymeric synthetic material.Examples of useful polymeric materials that may be useful in a porousmaterial include thermoplastic polymeric materials such as polyolefins(e.g., polypropylenes), polyurethanes, acetel materials, Teflon®materials, and the like; thermoset materials such as silicones; andmaterials that are otherwise curable, e.g., that can be cured byultraviolet radiation or chemical reactions, including curable materialssuch as curable urethanes, epoxies, acrylates, cyanoacrylates, and thelike. Any of these materials may be homopolymers, copolymers, or a blendor other combination of homopolymers, copolymers, or both. Othersuitable synthetic materials include metals (e.g. silver filigree,tantalum gauze mesh, and stainless steel mesh).

Examples of specific synthetic film and mesh materials are known and maybe suitable for use as a portion or piece of an implant such as an endportion or a central support portion. These include biocompatiblematerials that may be bioabsorbable or non-bioabsorbable, e.g., in theform of mesh materials. Suitable materials include cotton, linen, silk,polyamides (polyhexamethylene adipamide (nylon 66), polyhexamethylenesebacamide (nylon 610), polycapramide (nylon 6), polydodecanamide (nylon12), and polyhexamethylene isophthalamide (nylon 61), and copolymers andblends thereof), polyesters (e.g., polyethylene terephthalate, polybutylterephthalate, copolymers and blends thereof), fluoropolymers (e.g.,polytetrafluoroethylene and polyvinylidene fluoride), polyolefins (e.g.,polypropylene, including isotactic and syndiotactic polypropylene andblends thereof, as well as blends composed predominantly of isotactic orsyndiotactic polypropylene blended with heterotactic polypropylene, andpolyethylene), silicone, polygalactin, Silastic, polycaprolactone,polyglycolic acid, poly-L-lactic acid, poly-D-L-lactic acid andpolyphosphate esters.

Commercial examples of polymeric materials for use in an implant includeMARLEX (polypropylene) available from Bard of Covington, R.I.; PROLENE(polypropylene) and PROLENE Soft Polypropylene Mesh or Gynemesh(nonabsorbable synthetic surgical mesh), both available from Ethicon, ofNew Jersey; MERSILENE (polyethylene terephthalate) hernia mesh alsoavailable from Ethicon; GORE-TEX (expanded polytetrafluoroethylene)available from W. L. Gore and Associates, Phoenix, Ariz.; INTEPRO™polypropylene materials, and the polypropylene material used in thecommercially available MONARC™ or SPARC® sling systems, available fromAmerican Medical Systems, Inc. of Minnetonka, Minn. Commercial examplesof absorbable materials include DEXON (polyglycolic acid) available fromDavis and Geck of Danbury, Conn., and VICRYL available from Ethicon.

Suitable non-synthetic (biologic) implant materials include allografts,homografts, heterografts, autologous tissues, cadaveric fascia,autodermal grafts, dermal collagen grafts, autofascial heterografts,whole skin grafts, porcine dermal collagen, lyophilized aortichomografts, preserved dural homografts, bovine pericardium, and fascialata.

According to embodiments of the described implants, various additionalcomponents and features can be incorporated for added utility orconvenience, such as components and features that facilitateinstallation of an implant during a surgical procedure. For instance, atensioning member (e.g., suture) may be attached to an implant along aportion or entire length of an end portion for use in adding tension orin positioning an implant or a portion (e.g., extension) of an implant.Other embodiments of the invention do not require and can specificallyexclude a tensioning member such as a suture. Alternately or inaddition, an exemplary implant may include a removable sheath such as aplastic, transparent elongate tube, or the like, that can cover aportion or entire length of an end portion of an implant to facilitateinstallation by allowing a surgeon to apply tension or pressure on thesheath to indirectly apply pressure or tension to the end portion.Additionally or alternately, end portions of an implant may include aconnector or “dilator” tip at an end distal from a central supportmember, the connector being able to cooperate with an insertion tool(e.g., needle, tunneler, etc.) during a surgical procedure to eitherpush or pull the connector using the end of the insertion tool. Forexample, a tip may be a rigid plastic tip or dilator constructed toattach to an end of an elongate insertion tool by snapping or otherwisesecuring to the end of the insertion tool. The tool can then be used topush or pull the connector through a tissue passage to also bring theend portion of the implant through the tissue passage.

Different components of exemplary implants, e.g., support portion,central support portion, end portions, tensioning members (e.g.,sutures), etc., can be formed separately and assembled by methods suchas those described in pending patent application having U.S. Ser. No.11/115,655, filed on Apr. 26, 2005, entitled “SURGICAL IMPLANTS ANDRELATED METHODS,” the entirety of which is incorporated herein byreference.

According to an aspect of the invention, pelvic implants such asurethral slings are designed to exhibit good short-term fixationproperties. The implant can be designed to exhibit the ability to stickand hold into flesh when initially installed, without moving andpreferably without stretching. Various constructions of end portions andcentral support portions, and various implant material, have been foundto improve short-term fixation.

One mode of improving short-term fixation is to modify edge extensionsor (“barbs”) that extend from edges of a porous implant. Increasing ormaximizing the number, orientation, and stiffness of edge extensions canimprove the likelihood of the edge extensions (e.g., barbs) to dig intoflesh and hold the mesh in place, and can improve short-term fixationuntil tissue in growth occurs.

End portions of an implant of a porous material include side edges(“edges”) and edge extensions. The edge extensions exist due to theporous or “open pore” nature of the material used to prepare the endportion. The edge extensions can be treated or reinforced to cause theend portion to resist movement within tissue, during implantation, afterimplantation, or both. Reinforced edge extensions provide increasedfrictional resistance of an end portion from movement within the tissue,which provides desired short-term fixation properties of end portionswithin tissue during and immediately after installation, i.e., theability of the end portions to stick and hold into flesh when installedwithout moving and potentially without stretching. See Assignee's U.S.patent application Ser. No. 11/347,063, entitled “PELVIC IMPLANTS ANDRELATED METHODS,” filed Feb. 3, 2006, and incorporated herein byreference.

In alternate embodiments, or in combination with embodiments describedherein, an end portion or other support portion across a large area(e.g., an entire end portion, not just edge extensions) may be stiffenedto produce a support portion that takes on a shaped form that is biasedto be not flat. A non-flat form may include a curl, bend, wave, ortwist, etc., of the end portion, or other non-flat form, including oneor more of a lateral curl, a longitudinal wave, a longitudinal twist,etc. The shape may be imparted to the support portion by any mode ofshaping, such as by heat setting or application of a stiffening coating,or by other methods of stiffening. The stiffening and shaping couldproduce a support portion that exhibits a resilient yet biased (e.g.,semi-rigid) form or shape, such as a wave, twist, bend, curl, etc.; in anatural state the support portion would form a non-flat curl, wave,bend, or twist, but that form could be at least partially straightenedout by application of an opposing force on the support portion, to causethe support portion to become flat.

Thus, an end portion could be installed within a tissue passage, withthe tissue passage placing an opposing force on the end portion againstthe curl, twist, bend, wave, or other bias. The installed end portionwould exhibit a spring-like force or bias against tissue within thetissue path. This force or bias would produce a pressure between thebiased end portion and the tissue of the tissue path, resulting inincreased and improved contact forces between the end portion andtissue, and increase friction and short-term fixation.

Alternately or additionally, a central support portion or othersupportive portion of an implant (e.g., force-transfer portion) mayalso, optionally, be stiffened or formed into a desired shape, e.g., toconform to tissue to be supported. The shape may be rounded or curved,for example, to conform to a urethra, bladder, bladder neck, corpusspongiosum, etc., or other tissue being supported.

A portion of an implant may be treated to a stiffened, non-flat shape byany desired method, such as by thermoforming, heat treating, or byapplication of a polymeric or non-polymeric stiffening coating. Thecoating may be any biocompatible polymeric or non-polymeric coatingmaterial, and may be bioresorbable or non-bioresorbable. A stiffeningcoating can be applied using any suitable source and method to coat anend portion or a central support portion for stiffening and shaping intoa stiffened, biased, non-flat form. The coating may be a polymer thatpermanently stiffens edge the implant material. Alternately the coatingmay be of a biocompatible or bioresorbable material that temporarilystiffens the material, but is soluble and dissolves during chronicimplantation. Suitable soluble materials (described, for example, inU.S. Pat. Nos. 4,827,940, 5,531,783 and 5,716,391) may be selected fromamong mannitol, dextrose, sorbose, sucrose, or salts, e.g., sodiumchloride, potassium chloride, sodium carbonate, and polyvinylpyrrolidone(PVP).

According to other embodiments, short-term fixation of an implant can beincreased by constructing an implant, e.g., end portions of an implant,to include increased amounts of pores, porous material, or edgeextensions. As an example, an end portion may be prepared from multiplelayers of porous material placed and optionally secured together. One ormore of the layers may be of a larger or smaller size, dimension, poresize, filament size (of a mesh), etc., and one or the other may betwisted, wrapped, or otherwise non-flat, relative to the other.Optionally, one or more layers may be stiffened to a non-flat form, tobe biased in a shape such as curl, twist, bend, or wave, as describedabove.

By another construction, short or long-term fixation may be increased byproducing cuts, or slits, etc., within a portion of an implant such as acentral support portion or an end portion. Cuts can be in any direction,such as extending laterally, diagonally, or longitudinally, on an endportion or central support portion, etc. Cuts may be used to createbarbs or tines at major surfaces along the length of the end portion,similar to “edge extensions,” but positioned on the major surface areaof the implant. The cuts may also improve the ability of an implant toconform to a tissue upon installation. Similarly, a central supportportion may be cut or slit to allow a central support portion to exhibitincreased conformance to tissue that is supported.

An end portion of an implant can optionally include a tensioning memberor other reinforcement that can reduce length-wise elasticity of an endportion. As described in Assignee's copending U.S. Patent application2005/0143618 (U.S. Ser. No. 11/064,875) entitled “TransobturatorSurgical Articles and Methods,” the entirety of which is incorporatedherein by reference, an end portion may include a relatively inelastictensioning filament, suture, or other reinforcement, along lengths ofend portions. A tensioning suture may be constructed from a permanent orabsorbable material.

As an example, a low elasticity suture (like polyester woven) can beplaced to run through the length of an end portion and be tacked orotherwise joined to the end portion in one or several places along thelength. With multiple attachment points, a force applied to an endportion can be transmitted through a suture and applied to the endportion at each of the multiple attachment points, with the suturethereby transmitting the force to several areas of the end portionsimultaneously. In this way the end portion can invest into tissue as aunit and stretch as a unit instead of gradually weakening as it is beingpulled from one end. Observations indicate that the use of multipleattachment points for a tensioning member can result in a 2-fold(approx.) increase in fixation force with an elongate end portioncomprising a double layer of mesh (with one layer twisted), and apolyester suture.

A tensioning member such as a suture can preferably extend along endportions, but may not necessarily extend along a central support portionof the sling. A tensioning member may be attached to a sling end portionat one or multiple locations along a length of an end portion.Attachment may be by any useful method or mechanism, such as by welding(e.g. thermal or ultrasonic), knotting, anchoring, adhering (e.g. withand adhesive), or the like. A tensioning member in the form of a suturemay be absorbable or non-absorbable, and may be threaded into the lengthof an end portion starting for example at the central support portion,and extending to the end of the end portion, to allow for tensioningadjustment of the sling after placement in a patient.

Reinforcement of an implant, such as an end portion of an implant, canbe accomplished by methods described in Assignee's copending U.S. patentapplication Ser. No. 11/347,063, entitled “PELVIC IMPLANTS AND RELATEDMETHODS,” filed Feb. 3, 2006, the entirety of which is incorporatedherein by reference. According to embodiments of implants describedtherein, an end portion may be heat treated or “heat sealed” along edgesto produce reinforced edge extensions that improve friction betweentissue and implant. Stiffened or reinforced edge extensions result inedges of an end portion digging into tissue without deforming. Otherembodiments include edge extension reinforcement by use of adhesives,coatings, or added stiffening materials placed at or adjacent to edgeextensions.

Still additionally or in the alternate, an edge of an end portion mayinclude edge extensions that are not perpendicular to the end portion,but that are bent or otherwise oriented to improve frictional contactwith tissue, with or without stiffening (e.g., by heating,thermoforming, coating with a stiffening material, etc.). The edgeextension may point in a direction away from (out of) a major plane ofan end portion, or may be bent or pointed in a direction within theplane of the end portion but not perpendicular to the longitudinal axisof the end portion. Edge extensions may slant or point in a forward orbackward direction relative to the direction of insertion of an endportion during installation, in a manner that inhibits movement in a onedirection. See, e.g., FIGS. 8 and 9. For instance, a porous materialsuch as a knitted mesh or a film that has been cut or stamped to includeorifices or fenestrations, can include edge extensions that may bedirectional, e.g., not perpendicular to a longitudinal axis of an endportion, to provide directional holding force, e.g., directional to givemore holding force in one direction compared to another.

Short-term or long-term fixation of an implant may additionally oralternately be improved by use of an adhesive between an implant andtissue, during or after installation. Adhesive may be applied to endportions, a central support portion, or any other portion of an implant,for improved short-term or long-term fixation. Useful adhesives forbiological applications are available and will be understood, such asthe protein-based bioglue-type of adhesives, e.g., CryoLife BioGluesurgical adhesives. The adhesive may optionally be heat-activated,UV-activated, or moisture-cured, or activated by other radiation,catalyst, etc. Other useful adhesives include those based oncyano-acrylate chemistries.

An adhesive may be applied to an implant and adjacent tissue as desired,either before or during installation. By one method, an adhesive may beplaced at a tissue using a hollow installation needle or a needle thatincludes a lumen extending from a proximal end to a shaft or distal end.Adhesive can be dispensed from the needle as the needle is pulled orpushed through tissue along a tissue path. Adhesive may be dispensedfrom openings or pores along the length of a needle or at a distal endof a needle, as desired. The adhesive may be caused to be ejected fromthe needle by an actuating mechanism at the handle of the needle, andfrom a reservoir at the handle.

Long-term fixation is also a desirable property of a urethral implant,for male and female anatomy. For male anatomy in particular, a sling isexposed to loads that could cause a sling to move or stretch, whichshould be avoided. Resistance to stretching can be accomplished by anydesirable method, such as by use of a stretch-resistant material such asa polyester mesh, e.g., a silicone-coated polyester mesh; a large porepolypropylene mesh; or a coated or overmolded polypropylene mesh such asthat of the AMS Monarc® product with a silicone treatment; or heatsetting a polypropylene mesh such as that of the AMS Monarc® product tokeep the mesh from stretching.

Alternately or in addition, a relatively wider material may be used foran end portion of a urethral sling. Certain current products such as theMonarc® sling have end portions of approximately 1.1 cm width. A greaterwidth could improve long-term fixation of a urethral sling by creatingincreased contact between tissue and implant, e.g., creating a widerscaffold for tissue to grow into the implant and be able to spread outthe pelvic floor/urethral load over a greater area thus reducing thestress and lessening the likelihood of the mesh to stretch or fail.

Still additionally or alternately, relatively larger diameter filamentsmay be used to weave the mesh; or as, described, multiple the layers ofmesh may be used to increase the number of or volume of mesh filamentsper inch of mesh length, to increase the strength of mesh end portions.A relatively larger diameter mesh filament, such as polypropylene, maybe a polypropylene filament having a diameter of, e.g., from 0.010″ to0.050″, e.g., from 0.015″ to 0.04″.

One or more (e.g., two per end portion) non-absorbable suture, asdiscussed, may also be used to increase long-term strength of an endportion. Optionally, a suture may run along an entire length of animplant, including along two end portions, through a load-transitionportion and through a central support portion. Also optionally a suturemay be attached at multiple attachment points, at intermittent distances(intervals), e.g., every 0.5 cm, every 1 centimeter, every 2centimeters, every 3 centimeters, or up to 5 centimeters, and may beattached by any mechanism such as a knot, adhesive, heat treatment ofmesh material of the implant, etc. A tensioning suture may be of andesirable strength, material, or construction, etc. e.g., a diameter of0.006″ to 0.016″ or from 0.009″ to 0.016″.

Heat-setting portions or the entire length of an end portion may also beused to reduce the tendency of the mesh to unravel or stretch andincrease long-term strength of and end portion. This may beaccomplished, e.g., by adjusting pore size, selection of porous materialproperties, or coating a porous material, etc.

One particular example of a material that may be useful for an implant,e.g., end portion or central support portion, may be a material that hasgreater elasticity in one direction than in a different direction. Anexample is a polypropylene mesh (e.g., of the type referred to as “LPP”or “large pore polypropylene”) that shows reduced elasticity orstretching in one direction compared to a cross direction. Alongitudinal axis of an end portion can be formed using the relativelyinelastic direction of the material.

Another example of a material that may be a useful component of animplant can be a radiopaque feature, such as a filament, strand,tensioning member, etc., that can allow for visualization of an implantusing x-ray technology after surgery.

Yet another example of a material useful with an implant or portion ofan implant, in combination with any one or more of the featuresdescribed herein, may be a mesh that has a 2 bar knit mesh, as opposedto a 1 bar knit.

FIG. 1A shows an end portion according to the present description,designed to exhibit improved short-term or long-term tissue fixation.FIG. 1A shows two strips 2 and 4 of porous materials (e.g., mesh), eachhaving two major surfaces (6, 8, 10, and 12), stacked against each otherto produce end portion 11 that includes two layers of open porematerial. The two layers can be secured to each other by any fasteningmethod or mechanism, such a by sutures, staples, rivets, adhesives, tackwelds, thermal treatment of one or both layers, etc. The use of twolayers of open pore materials for an end portion can improve strength ofthe end portion and can also improve short-term fixation by increasingthe number of edge extensions available to contact tissue. The doublelayer construction is at the end portions of a sling, and notnecessarily at a central support portion.

FIG. 1A shows two pieces of open pore material being placed with majorsurfaces aligning in a width direction. If desired, alternateembodiments can place the two strips at offset positions so that edgesdo not align. FIGS. 1B and 1C illustrate a top view and a side view oftwo strips, 14 and 16, offset, and secured together by securement 18,which may be, e.g., heat treatment to melt polymer of strips 14 and 16,sutures, adhesive, etc.

Still alternately, different sized strips could be used for end portionsof FIGS. 1A and 1B (or any other end portion described or illustratedherein), such as relatively narrower open pore materials in a widthdirection, to increase the number of edge extensions per area of endportion.

In a similar, alternate embodiment from that of FIGS. 1A and 1B, an endportion may be of multiple layers, but based on a tubular construction.The end portion may be a tubular piece of open pore material folded flatagainst itself, or may maintain a somewhat round, oblong, or ovalcross-section, with pores exposed at different directions around thesurface. A tubular end portion may be made of an extruded porousmaterial or a sheet connected at a length-wise seam. Optionally, slitsmay be cut (e.g., laterally, longitudinally, diagonally, etc.) along thelength of a tubular end portion, to allow the end portion to conform totissue or a tissue path, to create edges that improve friction betweenthe end portion and tissue, and to allow ingrowth between tissue and theend portion.

FIG. 2 illustrates another embodiment of a two-layer end portion of asurgical implant, such as a urethral sling. To further increase thelikelihood of an end portion having edge extensions (e.g., sharp “tines”or “barbs”) enter tissue upon implantation, two layers of mesh could bestacked as in FIG. 2, with one twisted layer. One porous strip of an endportion can spiral like a cork-screw or helix in regular or irregularlengths or alternating or random directions, resulting in increasedcontact and frictional engagement between mesh and tissue. FIG. 2 showstwo strips 20 and 22 of a porous material (e.g., mesh). Strip 20 istwisted, and then stacked against strip 22, to produce end portion 24that includes two layers of open pore material, one layer being twisted.As illustrated, one layer can be twisted and one layer may be laid flat,with the layers joined together as desired, e.g., by sutures, staples,rivets, adhesives, tack welds, thermal treatment of one or both layers,etc. By having one layer twist relative to the other layer, edgeextensions or tines extend at every different angle from edges oftwisted mesh 20, increasing contact between edge extensions and tissue.When the implant is installed, and (optionally) a plastic sheath overthe end portion is removed, the end portion will open within a tissuepath and desirably engage tissue to prevent short-term movement of theend portion or sling.

FIG. 3 illustrates another embodiment of a multi-layer end portion of asurgical implant, such as a urethral sling. To further increase thelikelihood of the mesh to have sharp “tines” contacting tissue, threelayers of mesh are stacked as in FIG. 3 with two twisted layers. FIG. 3shows one central strip 34, and top and bottom strips 32 and 36, each ofa porous material (e.g., mesh). Top and bottom strips 32 and 36 aretwisted and then stacked against center strip 34, to produce end portion38 that includes three layers of open pore material, with a center layerone twisted top layer and one twisted bottom layer. Each of the layers32, 34, and 36, may be of the same or different materials, dimensions,pore and strand sizes (for a mesh), properties, etc. Twisted layers 32and 36 may be of similar twisted orientations, each being twistedregularly in the same direction and at similar lengths, or inalternating directions or dissimilar lengths, or with irregulartwist-lengths. So that top and bottom layers 32 and 36 twist and layflat against a major surface of central strip 34, top and bottom layers32 and 36 can be joined to central strip 34 as desired, e.g., bysutures, staples, rivets, adhesives, tack welds, thermal treatment ofone or both layers, etc. Two twisted layers cause edge extensions ortines of twisted top and bottom layers 32 and 36 to extend at differentangles to increase the number of edge extensions that contact tissue.

FIG. 4 illustrates another embodiment of a multi-layer end portion of asurgical implant, such as a urethral sling. To further increase thelikelihood of the implants having have sharp end extensions or “tines”contact tissue, two layers of twisted open pore mesh are stacked againsteach other in FIG. 4. Twisted strips 42 and 44, each of a porousmaterial (e.g., mesh), are twisted and then stacked and attachedtogether to produce end portion 46 that includes the two twisted layersof open pore material. Each of the layers 42 and 44 may be of the sameor different sizes and materials. Twisted layers 42 and 44 may be ofsimilar twisted orientations, each being twisted regularly in the samedirection and at similar lengths, or in alternating directions ordissimilar or random twist-lengths, or with irregular twist-lengths.Layers 40 and 42 can be twisted, laid flat, and then joined by anyfastening mechanism or technique, such as by suture, staple, rivet,adhesive, tack weld, thermal treatment of one or both layers, etc. Byhaving two twisted layers, edge extensions or tines of each of the twotwisted layers 42 and 44 can extend at different angles to increase thenumber of edge extensions that contact tissue.

FIGS. 5, 6, and 6A, illustrate end portions of polymeric open porematerial for use in an end portion, wherein the material is stiffenedand biased to a non-flat orientation, shape, or form. FIG. 5 shows endportion 48 in the form of an open pore material (e.g., mesh) thatexhibits a wave-form in its natural state. End portion 48 has beentreated or produced to exhibit a natural bias for this wave-form, e.g.,by heat-forming, thermoforming, molding, or coating with a stiffeningmaterial. A force applied in opposite directions at each end of endportion 48 would reduce the wave-form and at least partially straightenthe material, but upon release of the force the wave-form would return.This form causes the end portion to be biased toward the wave-form, andwhen the end portion is installed within a tissue path, the bias willcause portions of the wave-form end portion to exert pressure againsttissue defining the tissue path, increasing frictional contact betweenthe end portion and the tissue.

FIG. 6A shows end portion 50 in the form of an open pore material (e.g.,mesh) that exhibits a three-dimensional twisted helical, screw, orspiral form in a natural state. End portion 50 has been treated orproduced (e.g., molded) to exhibit a natural bias for this form, e.g.,by heat-forming, molding, coating with a stiffening material, etc. Aforce applied opposite to the twisted direction of end portion 50 mayreduce the degree or number of twists, and at least partially straightenthe end portion, but upon release of the force the twists wouldsubstantially return. This stiffened form causes the end portion to bebiased to include the twists. When the end portion is installed within atissue path, the bias will cause portions of the twisted-form to exertpressure against tissue defining the tissue path, increasing frictionalcontact between the end portion and the tissue.

FIG. 6B shows end portion 51 in the form of an open pore material (e.g.,mesh) that exhibits a lateral curve form in a natural state. End portion51 has been treated or produced (e.g., molded) to exhibit a natural biasfor this curled form, e.g., by heat-forming, molding, coating with astiffening material, etc. A force applied opposite to the curled formmay reduce the degree of the curl and at least partially straighten theend portion, but upon release of the force the curl would substantiallyreturn.

FIGS. 5, 6A, and 6B illustrate wave and spiral forms of end portions,but other forms would be useful as well for increasing force between aninstalled end portion and tissue of a tissue path. Further, while FIGS.5 and 6 illustrate single layer end portions, a shaped end portion(e.g., a heat formed end portion) could be used in combination withmultiple layer end portions, if desired, such as an any one of the endportions described herein or as illustrated, e.g., at FIGS. 1, 2, 3, 4,etc.

FIG. 6C shows an implant that includes a central support portion thatexhibits a stiffened, non-flat, curved, natural state. Implant 54includes end portions 52, which may be flat, non-flat, reinforced,multi-layer, etc., and central support portion 56. Central supportportion 56 has been treated or produced (e.g., molded) to exhibit anatural bias for a curved form, e.g., by heat-forming, molding, coatingwith a stiffening material, etc., as discussed herein for producing anon-flat end portion. A force applied opposite to the curled form mayreduce the degree of the curl and at least partially straighten the endportion, but upon release of the force the curl would substantiallyreturn. The curved form of central support portion 56 may be of a shapeor form adapted to a particular tissue such as the bladder, urethra,vagina, corpus spongiosum, BC muscle, etc., to allow the central supportportion to more closely align with a tissue upon implantation.

FIGS. 7A, 7B, and 7C, illustrate exemplary urethral slings havingtensioning members and widened central support portions (widened in asingle direction or “uni-laterally”). Referring to FIG. 7A, urethralsling 60 includes end portions 64, widened central support portion 62,and tensioning members 66. A tensioning member such as member 66 may be,e.g., a suture, heat-treated open pore material of end portions 64,adhesive, or the like, resulting in reduced length-wise elasticity ofend portions 64. As illustrated, tensioning member 66 is shown to be asuture attached at multiple points 68, by, e.g., adhesive, thermalwelding, sonic welding, adhesive, knots, or the like.

Referring to FIG. 7B, urethral sling 70 includes end portions 74,widened central support portion 72, and tensioning members 76, which maybe, e.g., a suture, heat-treated open pore material of end portions 74,adhesive, or the like, resulting in reduced length-wise elasticity ofend portions 74. As illustrated, tensioning members 76 are shown to be asutures attached at multiple points 78, by, e.g., adhesive, thermalwelding, sonic welding, adhesive, knots, or the like. Edge extensionreinforcement 75 is shown to be present along each of the side edges ofthe opposing end portions 74.

Referring to FIG. 7C, urethral sling 80 includes end portions 84,widened central support portion 82, and tensioning members 86, which maybe, e.g., a suture, heat-treated open pore material of end portions 84,adhesive, or the like, resulting in reduced length-wise elasticity ofend portions 84. As illustrated, tensioning members 86 are shown to be asutures attached at a single attachment point 88 per suture, e.g.,adhesive, thermal welding, sonic welding, adhesive, knot, or the like.Edge extension reinforcement 85 is shown to be present along each of theside edges of the opposing end portions 84.

FIGS. 7D, 7E, and 7F illustrate still other embodiments of urethralslings of the invention, each of which illustrates a urethral slinghaving a widened (bi-laterally) central support portion. FIG. 7D showssling 90 comprising widened central support portion 92, load-transitionportions 93, and end portions 94. Central support portion 92 andload-transition portions 93 are each of a single piece of material, andare connected to end portions 94 by attachments 96, extending the widthof end portions 94. Attachments 96 may be, e.g., heat-treated areas ofmelted polymeric material of end portions 94, central support portion92, or both. Alternately, attachments 96 may be sutures, adhesive, orthe like.

FIG. 7E shows sling 100 comprising widened central support portion 102,load-transition portions 103, and end portions 104. Central supportportion 102 and load-transition portions 103 are of a single piece ofmaterial and are connected to end portions 104 by attachments 106.Attachments 106 are illustrated to be polymeric rivets or adhesive, butmay alternately be another type of attachment such as sutures or meltedpolymeric implant material. Sutures 105 extend along end portions 104,two sutures 105 per end portion 104. Sutures 105 are attached to endportions 104 at multiple attachment points 107.

FIG. 7F shows sling 110 comprising widened central support portion 112,load-transition portions 113, and end portions 114. Central supportportion 112, load-transition portions 113, and end portions 114 are allof as single piece of material, such as a woven polymeric (e.g.,polypropylene) mesh. Two sutures 115 extend along the entire length ofimplant 110, including end portions 114, central support portion 112,and load-transfer portions 113. Sutures 115 are attached to implant 110at multiple attachment points 117.

Referring to FIG. 8, implant 140 includes support portion 148 and endportion 141. End portion 141 is an open pore material such as a meshthat includes solid portions (e.g., interwoven strands) 142 andapertures or pores 144 defined by solid portions 142. Edges 143 and 145include edge extensions 146, directed with a slant away from supportportion 148. Edge extensions 146 are illustrated as cut strands ofmaterial at the uneven edge of the open pore material defined by cutting(or forming) the open pore material along a line that includes adjacentpores. Extensions 146 are, e.g., cut strands of material that extendfrom the open pore material to define edges 143 and 145.

Referring to FIG. 9, implant 130 includes support portion 128 and endportion 131. End portion 131 is an open pore material that includessolid portions 122 and apertures or pores 124 defined by solid portions122. Edges 133 and 135 include edge extensions 126, directed with aslant away from support portion 128. Edge extensions 126 are illustratedas portions of solid material at the uneven edge of the open porematerial defined by cutting or forming the open pore material along aline that includes adjacent pores. Extensions 126 are the material thatextends from the open pore material to define edges 133 and 135.

Referring to FIG. 10, implant 160 includes central support portion 162and integral end portions 164. As illustrated, implant 160 is of asingle piece of material, such as a mesh, cut as one piece to theillustrated shape. Each of end portions 164 includes cuts (“slits” or“slots”) 166 that extend laterally, partially across the width of eachend portion 164, and that are located at multiple locations along thelengths of each of the two end portions 164. Each cut 166 exposesstrands of mesh that can contact tissue upon installation and increasefrictional forces between tissue and implant. Each cut 166 also allowsan end portion 164 to conform in shape to a tissue path. Cuts 166 arelateral, but one or more longitudinal or diagonal cuts in end portions164 may be used as an alternate to illustrated lateral cuts 166. Implant160 also includes cuts 168 extending longitudinally across portions ofcentral support portion 162, to allow central support portion 162 toconform to tissue being supported. Cuts 168 are longitudinal, but one ormore lateral or diagonal cuts in central support portion 162 may be usedas an alternate to illustrated longitudinal cuts 168.

FIGS. 7A, 7B, 7C, 7D, 7E, and 7F, and FIGS. 8, 9, and 10, do notspecifically show certain features end portions as described herein,e.g., multi-layer, heat-shaped or formed, coated to take a form of awave, twist, or curl, etc. According to the invention, however, any ofthese features may be included in the end portions of slings of FIGS.7A, 7B, 7C, 7D, 7E, 7F, 8, 9, and 10.

Referring to FIG. 11, an exemplary embodiment of a urethral slingassembly is depicted. Sling assembly 210 includes sling end portions 220and 221, and end connectors 212, which engage with free ends of righthand and left hand sling implantation tools (not shown). End connectors(or “dilators”) 212 can be shaped to dilate right and left passagesthrough body tissue formed by curved needles of right and left handimplantation tools in a transobturator procedure. While not specificallyillustrated, a sling as illustrated by FIG. 11 may include features ofend portions 220 and 221, as described herein, such as multiple layers,stiffening for shaping, features of edge extensions, etc.

Sling assembly 210 comprises a urethral sling with central supportportion 240, and end portions 242 and 240 enclosed within protectivesheaths 222 and extending from sling end connectors 212 to open sheathends 226 and 228. Protective sheaths 222 can be constructed of aflexible thin transparent plastic film that enables visual examinationof urethral sling end portions 220 and 221, and are sufficientlylubricious to pass easily through tissue passageways of a patient formedusing sling implantation tools. Sheaths 222 can include sheath indiciaor tear scores, perforations, or holes for assisting a surgeon inorienting urethral sling assembly 210 relative to a urethra or otherpelvic tissue during installation. The sling implant portion of assembly210 can be left in place chronically following implantation.

According to still other embodiments of the invention, ease of use of aneedle may improve by application of a coating to the needle to reducefriction between a needle and tissue, for improved passage throughtissue in creating a tissue path. Coatings can include parylene, Teflon(e.g., PTFE), hydrophilic low friction coatings, etc. Alternately or inaddition, plastic sheaths such as sheaths 222 of FIG. 11, may be coatedto reduce friction between sheaths 111 and tissue, upon installation,and allow sheaths 222 to move through tissue with less force.

Various embodiments of tools and implants described herein result inadvantages in pelvic procedures, irrespective of gender. Materials of animplant such as type of mesh, materials useful for a mesh, geometry of amesh, shape of a mesh, and placement of a mesh, can result in useful orimproved short or long term fixation of a pelvic implant. Materials,implants, and related methods described herein may provide improvedsupport for pelvic tissue such as the bladder, bladder neck, urethra,tissue supportive of the urethra, etc., from the position of the floorof the lower pelvic area. This provides resilience upon downwardpressure being placed on the pelvic tissue and there will be a push upfrom the sling when in the proper position.

The invention also relates to surgical assemblies, systems, or kits,that include an implant as described herein, including any one or anycombination of the described features. The implant may be useful forinstallation to treat a pelvic condition such as incontinence. Anexemplary kit or assembly can include a urethral sling and one or twosurgical instruments, each instrument having a handle portion, a needleportion having substantial structure in three dimensions, and a distalregion. A needle portion of one of the tools can be sized and shaped toextend between an incision substantially adjacent the obturator foramenon the patient's right side and a medial incision. The assembly also hasa second surgical instrument for use on a left side of a patient.

Exemplary transobturator methods may be useful for installing a urethralsling, and may include steps of creating a medial incision at theexternal male perineum or female vaginal, creating two external opposinglateral incisions substantially adjacent the patient's left and rightobturator foramen, and installing a urethral sling as described herein,end portions of which traverse the obturator foramen. The sling may beplaced using one or more surgical installation tools, by installing endportions of the sling between the medial and the lateral incisions andpassing through the obturator foramen. The end portion may be pushedthrough the tissue path at the leading edge of a needle, or may bepulled through the needle path using a trailing edge of the needle.

In more detail, an exemplary transobturator method for installing aurethral sling in a male anatomy can include a steps of creating amedial incision at the exterior perineum, creating an external lateralincision substantially adjacent the patient's obturator foramen,providing a surgical instrument having substantial structure in threedimensions, and providing an implant for treating the incontinence (aurethral sling), as described. The three-dimensional region of theneedle may be passed between the incisions and then the implant can beassociated with the instrument, e.g., at the end of thethree-dimensional region. For example, the needle may be passed from thelateral incision through the obturator foramen and to the medialincision, and the implant can be associated with the tip of the needleextending from the medial incision. The needle can then be pulled backthrough the incisions to pull the end portion of the implant from themedial incision, through the obturator foramen, and to the lateralincision.

Alternately, the implant can be associated with the needle beforepassing the needle between incisions. The needle, with the end portionof an implant associated with the needle tip, may then be passed betweenincisions, such as from the medial incision, through the obturatorforamen, and then through the lateral incision. This can be done on boththe right side and the left side.

In other embodiments of a transobturator method, a single needle may beuseful to place left and right end portions both left and right sides ofa patient. A single left-handed needle (alternately a singleright-handed needle) can be used to place a right side of the sling on apatient's right side, using a transobturator tissue path between aperineal incision and a patient's right-side lateral incision. In thesame procedure, the same left-handed needle may also be used to placethe opposite end portion on the patient's left side. While theleft-handed needle is not optimal for placement at the patient's leftside, it can be effective. Systems or kits of the invention can includea single left- or right-handed needle with an implant, for surgicalimplant according to this method.

By still other implantation methods, a variation of a “transobturator”method (considered for the present description to be a “transobturatormethod”) includes a method of inserting an implant through a medial,perineal incision and attaching an end portion of the implant to theobturator membrane. The anchor traverses or otherwise attaches to theobturator membrane. Other features of the inventive methods describedherein can be incorporated into such a technique, such as placement ofthe urethral sling below the BC or CS, approximation of the urethra toimprove continence (without the need for compression of the urethra),etc. This method avoids the need for lateral incisions.

To improve continence, the sling can be placed to support the urethra,by directly contacting the urethra or by indirectly supporting theurethra by contacting tissue supportive of the urethra, such as thecorpus spongiosum (CS) or bulbous cavernosum (BC) muscle. See,Assignee's copending U.S. patent application Ser. No. 11/347,047,entitled “TRANSOBTURATOR METHODS FOR INSTALLING SLING TO TREATINCONTINENCE, AND RELATED DEVICES,” filed Feb. 3, 2006, the entirety ofwhich is incorporated herein by reference.

Placement of an implant below the corpus spongiosum or below the bulbouscavernosum muscle may provide certain advantages that would provide forapproximating the BC muscle once the ends of the implant are tensionedso as to approximate pelvic tissue to a target and optimum position forsupport of the urethra, bladder, or supportive tissue, and hence providecontinence relief. In one example embodiment, the proposed pressure isabout 500 grams of force, but this may vary depending on the severity ofincontinence of the patient and is not limited to this stated amount.According to different embodiments of methods of treating incontinencein a male anatomy, an implant can be placed below the BC muscle or belowthe corpus spongiosum, and can be tensioned via pulling end portions toapproximate the BC muscle or CS, to place such tissue in a the finalposition that improves continence. Optionally, the implant may besutured to the BC muscle or CS.

An implant such as a urethral sling can be installed as described hereinwith the assistance of surgical equipment, instruments, or tools thatwill be understood to be of assistance in performing the presentsurgical methods. Examples of surgical tools that may be useful includetools of the type described herein and in U.S. Pat. No. 6,911,003 andU.S. Published Application No. 2003/0171644A1, which generally includeright and left-handed opposing helical installation tools.

Exemplary surgical tools can comprise a needle sized and shaped toeither a) initially extend through an incision substantially adjacent apatient's obturator foramen and then through the obturator foramen to amedial incision, or b) initially extend through a medial incision andsubsequently through the obturator foramen and then to an incisionsubstantially adjacent a patient's obturator foramen. Preferably, theneedle comprises a pair of ends having surfaces for affordingassociation with either an implantable sling material or a removablehandle. In one embodiment, a needle is sized and shaped for use oneither the patient's right side or left side (not both).

Embodiments of installation tools can include a substantially straightspacer portion emerging from an end of the handle portion preferablyalong a longitudinal axis of the handle. This helps afford convenientpassage of the needle using an ergonomic wrist roll adopted by somesurgeons.

A three-dimensional region of a needle can include a structure that canbe described as a variable spiral or helix portion extending from thedistal end of a straight spacer portion. A spiral portion can bevariable as the angle of the spiral portion changes between thebeginning of the spiral (e.g., the end of the spacer) and the distal endof the needle. The shape of the spiral portion can be designed to avoidover-insertion of the needle into the body, which helps avoid damage tothe sensitive structures in this region of the body.

A useful needle can have dimension and shape features particularlydesigned for male or female anatomy, such as for installation using amale transobturator procedure. The dimensions and shape features of thetool allow the needle to extend from a lateral incision adjacent theanterior side of the pubic bone, through the obturator foramen portionof the pubic bone, to a position on the posterior side of the pubicbone, and to then emerge from a medial incision made between thepatient's obturator foramen incisions. Alternate needles may be shapedto extend along the same tissue path in the opposite direction, enteringat the medial incision and exiting at the lateral incision. A largenumber of different sizes, shapes, and dimensions of needles aresuitable for the present invention.

In certain embodiments, a tool includes a handle or a portion of ahandle may exhibit a non-circular form when viewed along thelongitudinal axis of the handle. The non-circular cross-section can be,e.g., an oval, rectangle, rhombus, etc., having one dimension “width”that is greater than the dimension perpendicular to that “width.” Thenon-circular form will provide surfaces on the handle for a surgeon toplace pressure onto and to achieve a grip. The non-circularcross-sectional form also defines a midplane that is a plane thatincludes the longitudinal axis of the handle and extends along thewidest dimension of the handle when viewed in cross section.

According to embodiments of the invention, a needle distal end of a tool(measured at the tip of the needle distal end) may be located at aposition in space relative to the handle midplane and longitudinal axis,to provide the user with an ergonomic advantage. The ergonomic advantagemay relate to useful or optimized (e.g., increased) amounts of force andcontrol that can be applied at the needle distal end during thetransobturator installation procedure, meaning amounts of force,sensitivity, and control that the user will have over the needle distalend when manipulating the handle using the midplane for leverage orgrasping. As an example, a needle distal end may be located at an anglerelative to the midplane to provide an ergonomic strength advantage orcontrol advantage to a surgeon during particularly risky or sensitiveportions of a surgical procedure, such as portions of a surgicalprocedure that involve using the needle distal end to dissect a tissuepath through or near sensitive organs or tissues, e.g., traversing theobturator foramen. The angle “x” (see FIGS. 12A and 12B) between theneedle distal end and the midplane may provide the surgeon with the useof maximum hand or wrist strength and maximum control and precisionduring manipulation of the needle distal end through a sensitive orrisky tissue path, when applying pressure to a handle having a midplane.For transobturator procedures, the angle may be from 20 to 70 degrees,e.g., from 25 to 50 degrees, such as from 30 to 40 degrees from themidplane when viewed along longitudinal axis 231. See also Assignee'scopending U.S. patent application Ser. No. 11/347,553, entitled “NEEDLEDESIGN FOR MALE TRANSOBTURATOR SLING,” filed Feb. 3, 2006, the entiretyof which is incorporated herein by reference.

FIGS. 12A and 12B illustrate two views of a tool useful according to theinvention. FIG. 12A illustrates a view of tool 230 along a longitudinalaxis of the tool. FIG. 12B illustrates a side view of tool 230. Tool 230includes handle 232 and a needle extending longitudinally from an end ofhandle 232 along longitudinal axis 231 of the handle and tool. Theneedle includes spacer 234 and three-dimensional region 236 which may beconsidered to be a helix, a variable helix, or a spiral, etc. Diameter238 can be larger than diameters of relevant prior art tools, and maybe, for example, in the range from 2 to 5 centimeters, e.g., about 2.4inches. Length 242 of spacer 234 can be any desired length, with anexemplary length 242 being in the range from 1 to 5 inches, e.g., from1.75 to 2.25 inches. Length 240 of three-dimensional region 236 can beany desired length, such as in the range from 2.25 to 5 centimeters,e.g., from 2.4 to 2.5 inches. Angle y is approximately 45 degrees, andangle x is approximately 30 degrees, but may be otherwise, such as inthe range from 20 to 70 degrees, or from 30 to 60 degrees. Needle endportion 244, which includes a length of about one inch at the end of theneedle, is curved up until engaging portion 249, which is straight.

FIG. 12B shows an axis of needle end portion, line 252, or a planedefined by the needle end portion that is substantially orthogonal tothe longitudinal axis of handle 232. Distal end portion 244 can defineeither a line or a plane, depending on, e.g., whether the distal endportion is straight or curved. In FIG. 12A, distal end portion 244includes a curve, and as such defines a plane including needle distalend 250. This plane, illustrated as line 252, is substantiallyorthogonal to the longitudinal axis of tool 30. Radial distance 251 oftool 230 can be as desired, e.g., in the range from about from 0.7 to1.4 inches, e.g., from 0.9 to 1.1 inch for a male transobturator tool.Also shown at FIG. 12A, needle end portion 244, which includes a lengthof about one inch at the end of the needle, is curved up until engagingportion 249, which is straight.

Other modifications may also be useful for a tool, especially for use inan transobturator installation procedure in the male anatomy. Passing aneedle in a male anatomy may on average be more difficult than in afemale anatomy due to on-average greater muscle mass to pass through theobturator foramen, and due to the need to pass the needle through theperineal membrane versus a vaginal incision as in a woman. To assist inneedle passage in the male anatomy, dimensions of size and shape of athree-dimensional portion of a needle may be increased or otherwisemodified. A handle may be made to have a wider dimension, or modifiedshape or form, to allow improved grip and torque. FIG. 13, for example,illustrates an example of a tool that has a handle with anon-conventional grip. Tool 270 includes needle 274 and handle 272.Handle 272 includes a grip 276, that is oriented along an axis differentfrom needle shaft 274. This arrangement may allow a desirableorientation of the handle for use during a transobturator procedure.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill, in light of thisteaching, can generate additional embodiments and modifications withoutdeparting from the spirit of or exceeding the scope of the claimedinvention. Accordingly, it is to be understood that the drawings anddescriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A surgical implant comprising a central support portion and anelongate end portion attached to the central support portion, thecentral support portion being configured to support pelvic tissue, theelongate end portion having a length dimension extending away from thecentral support portion, and a width dimension, the length dimensionbeing greater than the width dimension, the elongate end portionextending from the central support portion and configured to extend topelvic tissue to support the central support portion, the end portioncomprising multiple layers of open pore elongate strip, wherein twoedges of two layers comprise edge extensions selected from the groupconsisting of a barb, a tine, a fiber, a strand, a filament, andcombinations thereof.
 2. The implant of claim 1, wherein each layercomprises a major surface and side edge, wherein the layers aresubstantially aligned along lengths of the end portions, and one layeris attached to a major surface of another layer.
 3. The implant of claim1, wherein layers are attached by a fastening mechanism selected fromthe group consisting of adhesive, suture, staple, thermoforming, andcombinations thereof.
 4. A method of preparing a surgical implantaccording to claim 1, the method comprising: providing at least two openpore elongate strips comprising major surfaces and edges; contacting amajor surface of one strip, to the other strip, attaching the strips. 5.A surgical system comprising, in combination, a urethral sling accordingto claim 1, and an installation tool comprising a handle and a curvedportion, the curved portion being curved in three-dimensions.
 6. Theimplant of claim 1, wherein one or more of the multiple layers of theend portion comprises a mesh.
 7. The implant of claim 1 wherein the twolayers of the end portion comprise a mesh.
 8. The implant of claim 1wherein each layer comprises a porous material selected from the groupconsisting of: a porous film, a porous braided material, a porous knitmaterial, a porous tied material, a porous mesh material, a porous wovenmaterial, a porous non-woven material, a porous fabric-type material,and combinations thereof.
 9. A method of preparing a surgical implantcomprising a central support portion and two elongate end portionsattached to the central support portion, the central support portioncomprising a stiffened non-flat curved form conforming to pelvic tissueselected from tissue selected from the group consisting of a bladder,urethra, vagina, corpus spongiosum, and bulbous cavernosum muscle, themethod comprising: providing an open pore elongate material in the formof a portion of an implant; treating the central support portion toproduce a central support portion having a stiffened non-flat curvedform of a shape adapted to align with a tissue selected from the groupconsisting of a bladder, urethra, vagina, corpus spongiosum, and bulbouscavernosum muscle; wherein the central support portion is treated by amethod selected from the group consisting of: heat treatment,thermoforming, coating with a stiffening material, and a combinationthereof.
 10. A method of claim 9 wherein the implant comprises anon-flat stiffened end portion comprising a form selected from alongitudinal wave, a lateral curl, a longitudinal curl, a bend, and alongitudinal twist.
 11. A method of claim 9 wherein the central supportportion is treated using a stiffening coating comprising polymerselected from the group consisting of mannitol, dextrose, sorbose,sucrose, a salt, sodium chloride, potassium chloride, sodium carbonate,polyvinylpyrrolidone, and combinations thereof.
 12. A surgical systemcomprising, in combination, a urethral sling comprising a centralsupport portion and an elongate end portion attached to the centralsupport portion, the central support portion comprising a stiffenednon-flat curved form conforming to pelvic tissue selected from the groupconsisting of a bladder, urethra, vagina, corpus spongiosum, and bulbouscavernosum muscle, wherein the central support portion is treated toachieve the non-flat form, by treatment selected from the groupconsisting of: heat treatment, thermoforming, coating with a stiffeningmaterial, and a combination thereof, and an installation tool comprisinga handle and a curved portion, the curved portion being curved inthree-dimensions.
 13. A method of implanting a urethral sling in a male,the method comprising providing a sling comprising a support portion andan elongate end portion attached to the support portion, the elongateend portion having a length dimension extending away from the centralsupport portion, and a width dimension, the length dimension beinggreater than the width dimension, providing a biological adhesive,installing the sling to contact pelvic tissue of a male using atransobturator tissue path, including creating a medial incision at theexternal male perineum, inserting the sling through the medial incisionto place the support portion at a location to support the urethra,contacting the end portion with biological adhesive, and placing the endportion through a tissue path extending between the location to supportthe urethra, and an obturator foramen, to secure the sling internally.14. A surgical implant comprising an elongate end portion, the elongateend portion comprising a suture running along a length of the endportion, the suture being attached at more than two attachment points.15. The implant of claim 14, wherein the suture is attached at intervalsin the range from 0.5 to 5 centimeters.
 16. The implant of claim 14,wherein the implant comprises 2 sutures, each extending along a lengthof the implant and each attached at intervals in the range from 0.5 to 5centimeters.
 17. The implant of claim 14 wherein the end portioncomprises two sutures running along a length of the end portion, eachsuture being attached at more than two attachment points.
 18. Theimplant of claim 14 wherein the implant comprises two elongate endportions each end portion extending from the central support portion,and wherein the central support portion has a width greater than thewidth of the elongate end portions.
 19. The implant of claim 18 whereinthe implant comprises a sheath along each elongate end portion.
 20. Theimplant of claim 18 comprising reinforced edge extensions.
 21. A kitcomprising an implant of claim 14 in combination with an insertion tool,the insertion tool comprising a handle and a helical needle, the handlecomprising a non-circular cross-section and a midplane.
 22. A kitaccording to claim 21 wherein the implant comprises two elongate endportions, each extending from the central support portion, wherein thecentral support portion has a width greater than a width of the elongateend portions, wherein the implant comprises a plastic sheath along eachelongate end portion, and wherein each sheath comprises a connector atan end of the sheath, the connector being capable of engaging a distalend of the helical needle.
 23. A surgical implant comprising a centralsupport portion and an elongate end portion attached to the centralsupport portion, the central support portion being configured to supportpelvic tissue, the elongate end portion having a length dimensionextending away from the central support portion, and a width dimension,the length dimension being greater than the width dimension, theelongate end portion extending from the central support portion andconfigured to extend to pelvic tissue to support the central supportportion, the end portion comprising multiple layers of open poreelongate strip, wherein two edges of two layers comprise edgeextensions, wherein each layer comprises a major surface, wherein thelayers are substantially offset along the lengths of the end portions,and one layer is attached to a major surface of another layer.
 24. Asurgical implant comprising a central support portion and an elongateend portion attached to the central support portion, the central supportportion being configured to support pelvic tissue, the elongate endportion having a length dimension extending away from the centralsupport portion, and a width dimension, the length dimension beinggreater than the width dimension, the elongate end portion extendingfrom the central support portion and configured to extend to pelvictissue to support the central support portion, the end portioncomprising multiple layers of open pore elongate strip, wherein twoedges of two layers comprise edge extensions, wherein a first layer ofopen pore elongate strip is twisted relative to a second layer of openpore elongate strip having first and second major surfaces and attachedto a first major surface of the second layer.
 25. The implant of claim24, wherein a third layer of open pore elongate strip is twistedrelative to the second layer and attached to the second major surface ofthe second layer.
 26. A surgical implant comprising a central supportportion and an elongate end portion attached to the central supportportion, the central support portion being configured to support pelvictissue, the elongate end portion having a length dimension extendingaway from the central support portion, and a width dimension, the lengthdimension being greater than the width dimension, the elongate endportion extending from the central support portion and configured toextend to pelvic tissue to support the central support portion, the endportion comprising multiple layers of open pore elongate strip, whereintwo edges of two layers comprise edge extensions, wherein a first layerand a second layer of open pore elongate strip are twisted and attachedto each other.
 27. A surgical implant comprising a central supportportion and an elongate end portion attached to the central supportportion, the central support portion being configured to support pelvictissue, the elongate end portion having a length dimension extendingaway from the central support portion, and a width dimension, the lengthdimension being greater than the width dimension, the elongate endportion extending from the central support portion and configured toextend to pelvic tissue to support the central support portion, the endportion comprising multiple layers of open pore elongate strip, whereintwo edges of two layers comprise edge extensions, wherein one or more ofthe multiple layers of the end portion comprises a mesh, and wherein oneor more of the multiple layers of the end portion comprises a twist,bend, curve or wave.
 28. A surgical implant comprising a central supportportion and an elongate end portion attached to the central supportportion, the central support portion being configured to support pelvictissue, the elongate end portion having a length dimension extendingaway from the central support portion, and a width dimension, the lengthdimension being greater than the width dimension, the elongate endportion extending from the central support portion and configured toextend to pelvic tissue to support the central support portion, the endportion comprising multiple layers of open pore elongate strip, whereintwo edges of two layers comprise edge extensions, wherein the two layersof the end portion comprise a mesh.
 29. A surgical implant comprising acentral support portion and an elongate end portion attached to thecentral support portion, the central support portion being configured tosupport pelvic tissue, the elongate end portion having a lengthdimension extending away from the central support portion, and a widthdimension, the length dimension being greater than the width dimension,the elongate end portion extending from the central support portion andconfigured to extend to pelvic tissue to support the central supportportion, the end portion comprising multiple layers of open poreelongate strip, wherein two edges of two layers comprise edge extensionsselected from the group consisting of a barb, a tine, a fiber, a strand,a filament, and combinations thereof, wherein each layer comprises amajor surface, wherein the layers are substantially offset along thelengths of the end portions, and one layer is attached to a majorsurface of another layer.
 30. A surgical implant comprising a centralsupport portion and an elongate end portion attached to the centralsupport portion, the central support portion being configured to supportpelvic tissue, the elongate end portion having a length dimensionextending away from the central support portion, and a width dimension,the length dimension being greater than the width dimension, theelongate end portion extending from the central support portion andconfigured to extend to pelvic tissue to support the central supportportion, the end portion comprising multiple layers of open poreelongate strip, wherein two edges of two layers comprise edgeextensions, and wherein each layer comprises a porous material selectedfrom the group consisting of: a porous film, a porous braided material,a porous knit material, a porous tied material, a porous mesh material,a porous woven material, a porous non-woven material, a porousfabric-type material, and combinations thereof.